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Study to Explore the Efficacy and Safety of BIO89-100 (Pegozafermin) in Participants With Severe Hypertriglyceridemia

NCT ID: NCT04541186

Last Updated: 2024-07-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-05-31

Brief Summary

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This study is designed to assess the efficacy, safety, and tolerability of different doses and dose regimens (once weekly \[QW\] or every 2 weeks \[Q2W\]), subcutaneous (SC) dosing of BIO89-100 (pegozafermin) compared to placebo in participants with severe hypertriglyceridemia (SHTG).

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Detailed Description

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Conditions

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Severe Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pegozafermin 9 mg QW

Participants received pegozafermin 9 mg QW as an SC injection for 8 weeks in the Main Study cohort.

Group Type EXPERIMENTAL

Pegozafermin

Intervention Type DRUG

Subcutaneous injection

Pegozafermin 18 mg QW

Participants received pegozafermin 18 mg QW as an SC injection for 8 weeks in the Main Study cohort.

Group Type EXPERIMENTAL

Pegozafermin

Intervention Type DRUG

Subcutaneous injection

Pegozafermin 27 mg QW

Participants received pegozafermin 27 mg QW as an SC injection for 8 weeks in the Main Study cohort or Fibrate Expansion cohort. Main Study and Fibrate Expansion pegozafermin 27 mg QW groups were pooled together due to low sample size in the expansion cohort.

Group Type EXPERIMENTAL

Pegozafermin

Intervention Type DRUG

Subcutaneous injection

Pegozafermin 36 mg Q2W

Participants received pegozafermin 36 mg Q2W as an SC injection for 8 weeks in the Main Study cohort.

Group Type EXPERIMENTAL

Pegozafermin

Intervention Type DRUG

Subcutaneous injection

Placebo

Matching placebo was injected at matching frequency per assigned cohort for 8 weeks in the Main Study cohort or Fibrate Expansion cohort. Main Study and Fibrate Expansion placebo groups were pooled together due to low sample size in the expansion cohort.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo

Interventions

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Pegozafermin

Subcutaneous injection

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type DRUG

Other Intervention Names

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BIO89-100

Eligibility Criteria

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Inclusion Criteria

1. Male or female age ≥21 to ≤75 years.
2. Screening fasting triglyceride ≥500 milligrams (mg)/deciliters (dL) and ≤2000 mg/dL.
3. Willing to maintain current eating and exercise habits from time of signing the informed consent and for the duration of the study.
4. Participants could be taking statins and/or prescription fish oil as background therapy or not be taking any background therapy.
5. Magnetic resonance imaging - whole liver proton density fat fraction (MRI-PDFF) of ≥6% for participants screened for the Fibrate Expansion cohort.

Exclusion Criteria

1. Uncontrolled or newly diagnosed hypertension.
2. Body mass index \>45 kilograms (kg)/meters squared (m\^2).
3. Receiving niacin, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, or supplements that could lower lipid levels.
4. Type 1 diabetes mellitus.
5. Diagnosis of Type 2 diabetes mellitus \<6 months prior to screening.
6. History of malignancy within 5 years prior to screening.
7. Participants with known lipoprotein lipase impairment or deficiency (Fredrickson Type 1), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type 3).
8. Clinically or otherwise documented cardiovascular or cerebrovascular disease.
9. Weight change ≥5% in 3 months prior to first screening visit or weight change ≥5% during screening or planning to try to lose weight during conduct of study.
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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89bio, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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89Bio Clinical Study Site

La Mesa, California, United States

Site Status

89Bio Clinical Study Site

San Francisco, California, United States

Site Status

89Bio Clinical Study Site

Clearwater, Florida, United States

Site Status

89Bio Clinical Study Site

Greenacres City, Florida, United States

Site Status

89Bio Clinical Study Site

Jacksonville, Florida, United States

Site Status

89Bio Clinical Study Site

Miami, Florida, United States

Site Status

89Bio Clinical Study Site

Miami, Florida, United States

Site Status

89Bio Clinical Study Site

Miami Lakes, Florida, United States

Site Status

89Bio Clinical Study Site

Miami Lakes, Florida, United States

Site Status

89Bio Clinical Study Site

North Miami Beach, Florida, United States

Site Status

89Bio Clinical Study Site

Orlando, Florida, United States

Site Status

89Bio Clinical Study Site

Tampa, Florida, United States

Site Status

89Bio Clinical Study Site

Lawrenceville, Georgia, United States

Site Status

89Bio Clinical Study Site

Quincy, Illinois, United States

Site Status

89Bio Clinical Study Site

Wauconda, Illinois, United States

Site Status

89Bio Clinical Study Site

West Des Moines, Iowa, United States

Site Status

89Bio Clinical Study Site

Louisville, Kentucky, United States

Site Status

89Bio Clinical Study Site

Olive Branch, Mississippi, United States

Site Status

89Bio Clinical Study Site

Albany, New York, United States

Site Status

89Bio Clinical Study Site

Greensboro, North Carolina, United States

Site Status

89Bio Clinical Study Site

Morganton, North Carolina, United States

Site Status

89Bio Clinical Study Site

Marion, Ohio, United States

Site Status

89Bio Clinical Study Site

Summerville, South Carolina, United States

Site Status

89Bio Clinical Study Site

Chattanooga, Tennessee, United States

Site Status

89Bio Clinical Study Site

Kingsport, Tennessee, United States

Site Status

89Bio Clinical Study Site

Austin, Texas, United States

Site Status

89Bio Clinical Study Site

Dallas, Texas, United States

Site Status

89Bio Clinical Study Site

Dallas, Texas, United States

Site Status

89Bio Clinical Study Site

Houston, Texas, United States

Site Status

89Bio Clinical Study Site

Lampasas, Texas, United States

Site Status

89Bio Clinical Study Site

Magnolia, Texas, United States

Site Status

89Bio Clinical Study Site

Manassas, Virginia, United States

Site Status

89Bio Clinical Study Site

Pardubice, , Czechia

Site Status

89Bio Clinical Study Site

Prague, , Czechia

Site Status

89Bio Clinical Study Site

Prague, , Czechia

Site Status

89Bio Clinical Study Site

Prague, , Czechia

Site Status

89Bio Clinical Study Site

Prague, , Czechia

Site Status

89Bio Clinical Study Site

Miskolc, Borsod-Abauj Zemplen county, Hungary

Site Status

89Bio Clinical Study Site

Baja, , Hungary

Site Status

89Bio Clinical Study Site

Békéscsaba, , Hungary

Site Status

89Bio Clinical Study Site

Budapest, , Hungary

Site Status

89Bio Clinical Study Site

Debrecen, , Hungary

Site Status

89Bio Clinical Study Site

Bialystok, , Poland

Site Status

89Bio Clinical Study Site

Bialystok, , Poland

Site Status

89Bio Clinical Study Site

Lodz, , Poland

Site Status

89Bio Clinical Study Site

Oświęcim, , Poland

Site Status

89Bio Clinical Study Site

Rzeszów, , Poland

Site Status

89Bio Clinical Study Site

Torun, , Poland

Site Status

Countries

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United States Czechia Hungary Poland

References

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Bhatt DL, Bays HE, Miller M, Cain JE 3rd, Wasilewska K, Andrawis NS, Parli T, Feng S, Sterling L, Tseng L, Hartsfield CL, Agollah GD, Mansbach H, Kastelein JJP; ENTRIGUE Principal Investigators. The FGF21 analog pegozafermin in severe hypertriglyceridemia: a randomized phase 2 trial. Nat Med. 2023 Jul;29(7):1782-1792. doi: 10.1038/s41591-023-02427-z. Epub 2023 Jun 24.

Reference Type RESULT
PMID: 37355760 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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BIO89-100-221

Identifier Type: -

Identifier Source: org_study_id

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